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LIQUID SECTION
CAPSULES: -
Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms
in which one or more medicinal and inert ingredients are enclosed in a small shell
or container usually made of gelatin.
There are two types of capsules, “hard” and “soft”. The hard capsule is also called
“two piece” as it consists of two pieces in the form of small cylinders closed at one
end, the shorter piece is called the “cap” which fits over the open end of the longer
piece, called the “body”. The soft gelatin capsule is also called as “one piece”.
Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug
tastes and odors can be masked by the tasteless gelatin shell. The administration of
liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.
ADVANTAGE OF CAPSULES:
Capsules mask the taste and odor of unpleasant drugs and can be easily
administered.
They are attractive in appearance.
They are slippery when moist and, hence, easy to swallow with a draught of
water.
As compared to tablets less adjuncts are required.
The shells are physiologically inert and easily and quickly digested in the
gastrointestinal tract.
They are economical.
They are easy to handle and carry.
The shells can be opacified (with titanium dioxide) or colored, to give
protection from light.
DISADVANTAGE OF CAPSULES:-
The drugs which are hygroscopic absorb water from the capsule shell making
it brittle and hence are not suitable for filling into capsules.
The concentrated solutions which require previous dilution are unsuitable for
capsules because if administered as such lead to irritation of stomach.
TYPES OF CAPSULES:-
Difference in the hard gelatin & soft gelatin capsules is that soft gelatin capsule
contains more plasticizer.
The raw materials used in the manufacture of both hard and soft gelatin capsules
are similar. Both contain gelatin, water, colorants and optional materials such as
process aids and preservatives.
1. GELATIN –gelatin is the major component of the capsules and has been the
material from which they have traditionally been made. Gelatin has been the raw
material of choice because of 3
the ability of a solution to gel to form a solid at a temperature just above ambie
nt temperate conditions, which enables a homogeneous film to be formed rapidly
on a mould pin.
The reason for this is that gelatin possesses the following basic properties:
• It is non-toxic, widely used in foodstuffs and acceptable for use worldwide.
• It is readily soluble in biological fluids at body temperature.
• It is good film-forming material, producing a strong flexible film
• The gelatin films are homogeneous in structure, which gives them strength.
PRODUCTION OF GELATIN:-
On a commercial scale, gelatin is made from by-products of the meat and leather
industry, mainly pork skins, pork and cattle bones, or split cattle hides. Contrary to
popular belief, horns and hooves are not commonly used. The raw materials are
prepared by different curing, acid, and alkali processes which are employed to
extract the dried collagen hydrolysate. The entire process takes several weeks.
The metal moulds at room temperature are dipped into a hot gelatin solution,
which gels to form a film. This is dried, cut to length, removed from the moulds
and the two parts are joined together, these processes are carried out as a
continuous process in large machines.
The completely automatic machine most commonly used for capsule production
consists of mechanisms for automatically dipping, spinning, drying, stripping,
trimming, and joining the capsules.
• Stainless steel pins are used on which the capsule is formed and controls some of
the final critical dimensions of the capsule.
• One hundred and fifty pairs of these pins are dipped in to gelatin sol of carefully
controlled viscosity to form caps and bodies simultaneously. The pins are usually
rotated to distribute the gelatin uniformly, during which time the gelatin may be set
or gelled by a blast of cool air.
• The pins are moved through a series of controlled air drying kilns for the gradual
and precisely controlled removal of water. The capsules are striped from the pins
by bronze jaws and trimmed to length by stationary knives while the capsule
halves are being spun in chuks or collets. After being trimmed to exact length, the
cap and body sections are joined and ejected from the machine. The entire cycle of
the machine lasts approximately 45 min.
• Thickness of the capsule wall is controlled by the viscosity of the gelatin solution
and the speed and time of dipping. Mold pin dimensions, precise drying, and
machine control relating to cut lengths are matters that are critical to the final
dimensions. Precise control of drying conditions is essential to the ultimate quality
of the cast film.
TYPES OF MATERIALS FOR FILLING INTO HARD GELATIN
CAPSULES:-
Hand operated and electrically operated machines are in practice for filling the
capsules but for small and quick dispensing hand operated machines are quite
economical.
All parts of the machine are made up of stainless steel. The machines are
generally supplied with additional loading trays, beds, and pin plates with
various diameters of holes so as to fill the desired size of the capsules. These
machines are very simple to operate, can be easily dismantled and reassembled
WORKING:-
The empty capsules are filled into the loading tray which is then placed over the
bed. By opening the handle, the bodies of the capsules are locked and caps
separated in the loading tray itself which is then removed by operating the liver.
The weighed amount of the drug to be filled in the capsules is placed in powder
tray already kept in position over the bed. Spread the powder with the help of a
powder spreader so as to fill the bodies of the capsules uniformly. Collect excess of
the powder on the platform of the powder tray. Lower the pin plate and move it
downward so as to press the powder in the bodies. Remove the powder tray and
place the caps holding tray in position. Press the caps with the help of plate with
rubber top and operate the lever to unlock the cap and body of the capsules.
Remove the loading tray and collect the filled capsules in a tray. With 200 hole
machine about 5000 capsules can be filled per hour and with 300 hole machine
7500 capsules can be filled per hour.
CAPSULE FILLING POROCESS:-
(SIZE OF CAPSULES)
SOFT GELATIN CAPSULE :-
A soft gel (a soft gelatin capsule) is a solid capsule (outer shell) surrounding a
liquid or semi-solid center (inner fill). An active ingredient can be incorporated
into the outer shell, the inner fill, or both.
They are most suitable for liquids and semisolids and are widely used, in spherical
and ovoid forms for vitamin preparations such as cod liver oil, vitamins A and D
and multiple vitamins.
ADVANTAGE:-
1. Ease of use - easy to swallow, no taste, unit dose delivery, temper proof.
2. Versatile
i. Accommodates a wide variety of compounds filled as a
semisolid, liquid, gel or paste.
ii. Wide variety of colors, shapes and sizes
iii. Immediate or delayed drug delivery-can be used to improve
bioavailability by delivering drug in solution or other
absorption enhancing media
DISADVANTAGE:-
1. Requires special manufacturing equipment
2. Stability concerns with highly water soluble compounds, and
compounds susceptible to hydrolysis
3. Limited choices of excipients/carriers compatible with the
gelatin
Soft capsules are usually formed, filled, and sealed in one operation. However,
shells for extemporaneous use are sometimes prefabricated. Liquids may be
incorporated directly. Solids are usually dissolved or dispersed in a suitable
excipient(s) to give a solution, suspension or dispersion of paste-like consistency.
In-process controls during soft capsule production should include the viscosity of
the contents, and the uniformity of mass, capsule size, integrity of the seals, and
disintegration or dissolution rate (e.g. for modified-release capsules) of the finished
dosage form.
PLASTICIZERS:-
These are used to make the soft gel shell elastic and pliable. They usually account
for 20-30%. The most common plasticizers used in soft gels is glycerol, although
sorbitol and propylene glycol are used frequently often in combination with
glycerol. The amount and choice of the plasticizer contribute to the hardness of the
final product and may even affect its dissolution or disintegration characteristics,
as well as its physical and chemical stability. Plasticizers are selected on the basis
of their compatibility with the fill formulation, ease of processing, and the desired
properties of the final soft gel, including hardness, appearance, handling
characteristics and physical stability. One of the most important aspect of soft gel
formulation is to ensure that there is minimum interaction or migration between the
liquid fill matrix and the soft gel shell.
WATER:-
The other essential component of the soft gel shell is water. Water usually accounts
for 30-40 % of the wet gel formulation and its presence is important to ensure
proper processing during gel preparation and soft gel encapsulation. Following
encapsulation, excess water is removed from the soft gels through controlled
drying. In dry gels the equilibrium water content is typically in the range 5-8%
w/w, which represents the proportion of water that is bound to the gelatin in the
soft gel shell. This level of water is important for good physical stability, because
in harsh storage conditions soft gels will become either too soft and fuse together,
or too hard and embrittled.
Whether capsules are produced on a small scale or large scale all of them are
required to pass not only the disintegration test, weight variation test and
percentage of medicament test but a visual inspection must be made as they roll off
the capsule machine onto a conveyor belt regarding uniformity in shape, size, color
and filling. As the capsules moves in front of the inspectors the visibly defective or
suspected of being less than the perfect are picked out.
The hard and soft gelatin capsules should be subjected to following tests for their
standardization.
1. Shape and size
2. Color
3. Thickness of capsule shell
4. Leaking test for semi-solid and liquid ingredients from soft capsules
5. Disintegration tests
6. Weight variation test
7. Percentage of medicament test
In official books the following quality control tests are recommended for capsules:
INTRODUCTION:-
Or
TYPES OF SYRUP:-
1. Aromatic or Adjuvant Syrup
2. Medicated Syrup
Aromatic or Adjuvant Syrup:-
They are mostly used to improve the taste of salty, bitter, or otherwise unpleasant
mixtures.
Medicated Syrup:-
DISADVANTAGE OF SYRUP:-
FORMULATION OF SYRUP:-
I. KOFGON SYRUP ;-
COMPOSITION:-
Each 5ml. contains
Salbutamol - I.P. 2.00 mg.
Bromhexine hydrochloride - I.P. 4.00 mg.
Benzoic Acid - I.P. 20.00 mg.
(As preservative)
Flavored Syrupy Base - q.s.
Colour - Sunset Yellow
vMANUFACTURING PROCESS:-
Syrup base is added to the container fixed with accessory equipment.
The base is distilled as per the need. The agitator is then started.
Solubilisation is then done & solvents are added to it.
Active ingredients are then added to the mixture.
Those bottles are then sealed & again checked for any cracks.
Sampling, labeling& packaging is then done.
PHARMACEUTICAL APPLICATIONS :
All types of throat congestitis, irritation, cough, acute bronchitis, bronchial asthma,
tropical oesonophilia.
Bottle Cap Sealing Machine : Portable, hand operated equipment with two extra
cap holders of different sizes. Totally casted machine hand operated
REFERENCES-